Post-Approval Studies (PAS)

The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

The Medtronic Post-Approval Network (PAN) is designed to conduct non-randomized, active prospective post-market Surveillance. The Registry is sponsored by Medtronic and is comprised of a global network of hospitals, clinics and clinicians from which reliable ¿real world¿ product safety and patient clinical outcome information is generated. Primary objective: To demonstrate that the complication- free probability is greater than 92.5% at five years post- implant for the high voltage DF4 connector.

Study Population Description

This study will consist of 1,778 patients implanted with a DF-

4 connector system, enrolled at one of approximately 150 centers globally. Subjects that meet the following inclusion criteria and do not meet any of the following exclusion criteria are eligible for enrollment.